FR2848853A1 - Treatment of post-menopausal syndrome, using pharmaceutical or dietetic compositions containing synergistic combination of soya isoflavones, soya saponins and vitamin K - Google Patents

Treatment of post-menopausal syndrome, using pharmaceutical or dietetic compositions containing synergistic combination of soya isoflavones, soya saponins and vitamin K Download PDF

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Publication number
FR2848853A1
FR2848853A1 FR0304213A FR0304213A FR2848853A1 FR 2848853 A1 FR2848853 A1 FR 2848853A1 FR 0304213 A FR0304213 A FR 0304213A FR 0304213 A FR0304213 A FR 0304213A FR 2848853 A1 FR2848853 A1 FR 2848853A1
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FR
France
Prior art keywords
vitamin
soya
saponins
isoflavones
post
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
FR0304213A
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French (fr)
Inventor
Alessandro Heyda
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MARFARMA Srl
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MARFARMA Srl
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Publication of FR2848853A1 publication Critical patent/FR2848853A1/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/15Vitamins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/12Ketones
    • A61K31/122Ketones having the oxygen directly attached to a ring, e.g. quinones, vitamin K1, anthralin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23VINDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00Food compositions, function of food ingredients or processes for food or foodstuffs
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55511Organic adjuvants
    • A61K2039/55577Saponins; Quil A; QS21; ISCOMS

Abstract

Pharmaceutical, nutraceutical, dietetic or nutritional compositions (A) for the treatment of post-menopausal syndrome comprise soya isoflavones (I), soya saponins (II) and vitamin K (III).

Description

ii

La présente invention concerne des compositions pharmaceutiques, nutraceutiques, diététiques, nutritionnelles pour le traitement du syndrome postménopausique, contenant: a) des saponines de soja; b) des isoflavones de soja; c) de la vitamine K. Le syndrome post-ménopausique, caractérisé par des bouffées de chaleur, transpiration, céphalée, nervosisme, dépression, et ostéoporose, est depuis longtemps traité avec la thérapie hormonale substitutive avec des 10 oestrogènes, dont les risques sont cependant bien connus En effet l'administration d'oestrogènes, surtout pendant une longue période, peut favoriser l'apparition de tumeurs provoquées par ceux-ci Une alternative à la thérapie substitutive avec des oestrogènes est celle qui utilise des isoflavones de soja, dont I 'activité similaire à celle des oestrogènes est abondamment 15 documentée par la littérature Cette activité similaire à celle des oestrogènes se révèle extrêmement utile dans le traitement du syndrome post-ménopausique, car non seulement elle provoque une réduction des symptômes comme les bouffées de chaleur, nervosisme, maux de tête, palpitations, mais elle permet aussi de lutter contre les problèmes liés à l'ostéoporose, grâce à son action 20 inhibitrice sur la tyrosine kinase, qui permet à son tour l'inhibition de l'activité ostéoclastique, avec l'augmentation consécutive de la densité minérale osseuse.  The present invention relates to pharmaceutical, nutraceutical, dietetic and nutritional compositions for the treatment of postmenopausal syndrome, containing: a) soy saponins; b) soy isoflavones; c) vitamin K. Post-menopausal syndrome, characterized by hot flashes, sweating, headache, nervousness, depression, and osteoporosis, has long been treated with hormone replacement therapy with estrogens, the risks of which are, however, well known Indeed the administration of estrogens, especially during a long period, can favor the appearance of tumors caused by these. An alternative to the replacement therapy with estrogens is that which uses soy isoflavones, of which I ' activity similar to that of estrogens is abundantly documented in the literature This activity similar to that of estrogens proves to be extremely useful in the treatment of post-menopausal syndrome, because not only does it cause a reduction in symptoms such as hot flushes, nervousness, headache, palpitations, but it also helps fight problems related to osteoporosis, thanks to its inhibitory action on tyrosine kinase, which in turn allows the inhibition of osteoclastic activity, with the consequent increase in bone mineral density.

L'action de réduction et de lutte contre la prolifération du cholestérol des saponines de soja est bien connue dans la littérature.  The action of reducing and combating the proliferation of cholesterol from soy saponins is well known in the literature.

N Binkley et al (Am J Clin Nutr 200; 72: 1523-8) a divulgué qu'un 25 apport insuffisant en vitamine K dans le régime alimentaire contribue au développement d'ostéoporoses, et qu'une intégration en vitamine K réduit la concentration plasmatique d'ostéocalcine.  N Binkley et al (Am J Clin Nutr 200; 72: 1523-8) disclosed that insufficient intake of vitamin K in the diet contributes to the development of osteoporosis, and that integration of vitamin K reduces the concentration osteocalcin plasma.

WO 02074308 décrit des compositions utiles pour la prévention de l'ostéoporose, contenant, entre autres, des isoflavones de soja et de la vitamine 30 K. On a à présent découvert que l'association de saponines de soja, d'isoflavones de soja et de vitamine K est particulièrement efficace dans le traitement du syndrome post-ménopausique Plus particulièrement, cette association permet d'obtenir une disparition presque totale des bouffées de 35 chaleur et une prévention très efficace de l'ostéoporose.  WO 02074308 describes compositions useful for the prevention of osteoporosis, containing, among other things, soy isoflavones and vitamin 30 K. It has now been discovered that the combination of soy saponins, soy isoflavones and of vitamin K is particularly effective in the treatment of post-menopausal syndrome More particularly, this combination makes it possible to obtain an almost total disappearance of hot flashes and a very effective prevention of osteoporosis.

C'est donc pourquoi la présente invention a pour objet des compositions pharmaceutiques, nutraceutiques, diététiques, nutritionnelles contenant des saponines de soja, des isoflavones de soja et de la vitamine K, pour le traitement du syndrome post-ménopausique.  This is why the present invention relates to pharmaceutical, nutraceutical, dietetic and nutritional compositions containing soy saponins, soy isoflavones and vitamin K, for the treatment of post-menopausal syndrome.

Les compositions de la présente invention montrent un effet supérieur à celui obtenu par la somme des effets obtenus suite à l'administration séparée de 5 chacun des éléments de 1 ' association Cet effet supérieur est apparemment d à une synergie entre saponines/isoflavones et vitamine K, qui permet d'obtenir une réponse plus rapide et plus efficace.  The compositions of the present invention show an effect greater than that obtained by the sum of the effects obtained following the separate administration of each of the elements of the association. This superior effect is apparently due to a synergy between saponins / isoflavones and vitamin K , which provides a faster and more efficient response.

De préférence, les saponines de soja et les isoflavones de soja proviennent toutes les deux d'un seul extrait de soja, caractérisé par un titre 10 défini en saponines et en isoflavones D'après l'invention, cet extrait de soja contiendra de préférence d'environ 50 à environ 200 mg de saponines et d' environ 40 à environ 150 mg d'isoflavones.  Preferably, the soy saponins and the soy isoflavones both come from a single soy extract, characterized by a defined titer of saponins and isoflavones. According to the invention, this soy extract will preferably contain '' about 50 to about 200 mg of saponins and about 40 to about 150 mg of isoflavones.

La teneur en vitamine K dans les compositions de l'invention variera d'environ 0,5 à environ 250 mcg, de préférence entre 50 et 150 mcg.  The content of vitamin K in the compositions of the invention will vary from about 0.5 to about 250 mcg, preferably between 50 and 150 mcg.

Les compositions de la présente invention pourront être formulées de manière appropriée pour l'administration par voie orale et seront préparées selon les méthodes conventionnelles bien connues dans le secteur de la technique pharmaceutique, comme celles décrites dans "Remington's Pharmaceutical Handbook", Mack Publishing Co, N Y, USA, en utilisant des excipients, 20 diluants, agents de charge, anti- agglomérants acceptables pour leur emploi final. On reporte ci après un exemple de formulation de l'invention.  The compositions of the present invention may be formulated appropriately for oral administration and will be prepared according to conventional methods well known in the pharmaceutical industry, such as those described in "Remington's Pharmaceutical Handbook", Mack Publishing Co, NY, USA, using excipients, diluents, bulking agents, anti-caking agents acceptable for their end use. An example of formulation of the invention is given below.

Exemple Comprimés de 900 mg Ingrédient Quantité Extrait de soja titré en: 533 mg 26 % de saponines (correspondant à 141,24 mg) % d'isoflavones (correspondant à 80 mg) Vitamine K 1 100 mcg Cellulose microcristalline 135,267 Phosphate de calcium 100,000 Amidon de mas 80,000 Polyvinylpyrrolidone 25,000 Bioxyde de silicium 15,000 Stéarate de magnésium 9,000  Example 900 mg tablets Ingredient Quantity Soy extract titrated in: 533 mg 26% saponins (corresponding to 141.24 mg)% isoflavones (corresponding to 80 mg) Vitamin K 1 100 mcg Microcrystalline cellulose 135.267 Calcium phosphate 100,000 Starch of mas 80,000 Polyvinylpyrrolidone 25,000 Silicon dioxide 15,000 Magnesium stearate 9,000

Claims (3)

REVENDICATIONS 1 Compositions pharmaceutiques, nutraceutiques, diététiques, nutritionnelles pour le traitement du syndrome post-ménopausique, contenant: a) des isoflavones de soja; b) des saponines de soja; c) de la vitamine K.  1 Pharmaceutical, nutraceutical, dietetic and nutritional compositions for the treatment of post-menopausal syndrome, containing: a) soy isoflavones; b) soy saponins; c) vitamin K. 2 Compositions selon la revendication 1, contenant: de 50 à 200 mg de saponines de soja; de 40 a 150 mg d'isoflavones de soja; 10 de 0,5 à 250 mcg de vitamine K.2 Compositions according to claim 1, containing: from 50 to 200 mg of soy saponins; 40 to 150 mg of soy isoflavones; 10 from 0.5 to 250 mcg of vitamin K. 3 Composition selon les revendications 1 et 2, contenant: Extrait de soja titré en: 533 mg 26 % de saponines (correspondant à 141,24 mg) % d'isoflavones (correspondant à 80 mg) Vitamine K 1 100 mcg Cellulose microcristalline 135,267 Phosphate de calcium 100,000 Amidon de mas 80,000 Polyvinylpyrrolidone 25,000 Bioxyde de silicium 15,000 Stéarate de magnésium 9,000 4 Utilisation d'une composition selon l'une quelconque des revendications précédentes pour la préparation d'un médicament pour le traitement du syndrome post-ménopausique.3 Composition according to Claims 1 and 2, containing: Soy extract titrated in: 533 mg 26% saponins (corresponding to 141.24 mg)% isoflavones (corresponding to 80 mg) Vitamin K 1 100 mcg Microcrystalline cellulose 135.267 Phosphate of calcium 100,000 Mas starch 80,000 Polyvinylpyrrolidone 25,000 Silicon dioxide 15,000 Magnesium stearate 9,000 4 Use of a composition according to any one of the preceding claims for the preparation of a medicament for the treatment of post-menopausal syndrome.
FR0304213A 2002-12-20 2003-04-04 Treatment of post-menopausal syndrome, using pharmaceutical or dietetic compositions containing synergistic combination of soya isoflavones, soya saponins and vitamin K Pending FR2848853A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IT002723A ITMI20022723A1 (en) 2002-12-20 2002-12-20 COMPOSITIONS FOR THE TREATMENT OF POST-MENOPAUSE SYNDROME.

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FR2848853A1 true FR2848853A1 (en) 2004-06-25

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007021166A1 (en) * 2005-08-12 2007-02-22 World-Trade Import-Export, Wtie, A.G. Isoflavone composition for the treatment of menopausal physiological disorders and symptoms

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19732866A1 (en) * 1997-07-30 1999-02-18 Indena Spa Soya extract containing group B soya saponin(s)
EP0906761A2 (en) * 1997-10-02 1999-04-07 Archer-Daniels-Midland Company Method of preparing and using phytochemicals
US6280777B1 (en) * 1997-07-30 2001-08-28 Indena S.P.A. Soya extract, process for its preparation and pharmaceutical composition
WO2002074308A1 (en) * 2001-03-15 2002-09-26 Roche Vitamins Ag Composition for the prevention of osteoporosis comprising a combination of isoflavones and polyunsaturated fatty acids
EP1321149A1 (en) * 2001-12-18 2003-06-25 Marfarma S.R.L. Compositions for relieving symptoms of menopausal syndrome

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE19732866A1 (en) * 1997-07-30 1999-02-18 Indena Spa Soya extract containing group B soya saponin(s)
US6280777B1 (en) * 1997-07-30 2001-08-28 Indena S.P.A. Soya extract, process for its preparation and pharmaceutical composition
EP0906761A2 (en) * 1997-10-02 1999-04-07 Archer-Daniels-Midland Company Method of preparing and using phytochemicals
WO2002074308A1 (en) * 2001-03-15 2002-09-26 Roche Vitamins Ag Composition for the prevention of osteoporosis comprising a combination of isoflavones and polyunsaturated fatty acids
EP1321149A1 (en) * 2001-12-18 2003-06-25 Marfarma S.R.L. Compositions for relieving symptoms of menopausal syndrome

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
HIDAKA TAKAO ET AL: "Treatment for patients with postmenopausal osteoporosis who have been placed on HRT and show a decrease in bone mineral density: effects of concomitant administration of vitamin K(2).", JOURNAL OF BONE AND MINERAL METABOLISM. 2002, vol. 20, no. 4, 2002, pages 235 - 239, XP001206344, ISSN: 0914-8779 *
SCAMBIA G ET AL: "Clinical effects of a standardized soy extract in postmenopausal women: A pilot study", MENOPAUSE 2000 UNITED STATES, vol. 7, no. 2, 2000, pages 105 - 111, XP009048138, ISSN: 1072-3714 *
THIEDKE C C: "Menopause", CLINICS IN FAMILY PRACTICE 2002 UNITED STATES, vol. 4, no. 4, 2002, pages 985 - 1003, XP009048144, ISSN: 1522-5720 *
YAMAGUCHI M ET AL: "Effect of vitamin K2 (menaquinone-7) in fermented soybean (natto) on bone loss in ovariectomized rats.", JOURNAL OF BONE AND MINERAL METABOLISM. 1999, vol. 17, no. 1, 1999, pages 23 - 29, XP001205787, ISSN: 0914-8779 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2007021166A1 (en) * 2005-08-12 2007-02-22 World-Trade Import-Export, Wtie, A.G. Isoflavone composition for the treatment of menopausal physiological disorders and symptoms

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